Biosimilar bill offers 12 years of market exclusivity

Biotech lobbyists loudly cheered a newly-introduced bill that offers 12 years of market exclusivity to branded biologics before they have to confront a generic competitor. Reps. Anna G. Eshoo (D-CA), Joe Barton (R-TX) and Jay Inslee (D-WA) introduced the bill, which quickly earned rave reviews [1] from BIO.

The bill "provides patients with the right balance between innovation and competition," said BIO President Jim Greenwood.

Greenwood and the rest of the biotech industry, though, face tough legislative competition from a bill offered by Henry Waxman [2] that provides only five years of exclusivity for biologics. After years of wrangling over issues like the safety of biosimilars and the kind of discounts that they could offer the marketplace, lawmakers are now down to only one: How much time should a biologic be given before a biosimilar is allowed to compete with it?

For biotech companies, the difference between five years and 12 years of exclusivity could amount to billions of dollars. Mega-blockbusters earn more than $2 billion a year. But there's a lot of support in Congress to pass those savings on to consumers as soon as possible. And the debate appears headed for a final resolution sometime this year.

- read the report [3] from Dow Jones
- here's BIO's response [1]

Related Articles:
Lawmakers propose biogeneric bill [2]
Obama to back biogenerics [4]
Small biotech campaigns for biogenerics law [5]
Biotech's next big opportunity: Follow-ons? [6]